Metabolite Tales Blog

JULY 5, 2023

Figure 1 Metabolism of simeprevir Glecaprevir (ABT493/A-1282576) is another antiviral drug for the treatment of chronic hepatitis C which also undergoes limited CYP3A4/5 mediated metabolism in vitro , and for which all human metabolites were present in at least one animal species. link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Agency IQ

DECEMBER 11, 2023

OCE leadership and staff also kept AgencyIQ staff very busy in 2023 as they attended and presented at countless meetings. The side effects of some anticancer treatments can result in dose interruptions or de-escalations, or even outright discontinuation of an efficacious therapy. months, according to the GSK presentation.

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Agency IQ

OCTOBER 20, 2023

Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Developing biosimilars is an extensive and expensive process.

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Agency IQ

FEBRUARY 23, 2024

Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies. LILLIAN SIU, an oncologist and clinical trialist at Toronto’s Princess Margaret Cancer Centre, was a panelist on the day’s second session.

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Agency IQ

SEPTEMBER 29, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Agency IQ

JUNE 2, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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The Anticancer Fund

JUNE 7, 2022

Please get in touch if you’re interested in discussing research based on the findings presented below ( info@anticancerfund.org ). All articles need to be critically assessed and viewed in their broader research context.

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Agency IQ

OCTOBER 27, 2023

Government shutdown: At present, the U.S. While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published. federal government has appropriated funding through November 17.

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Agency IQ

JULY 8, 2024

Title Type Comments Close Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564 Draft Guidance July 5 Consideration of Enforcement Policies for Tests During a Section 564 Declared Emergency Draft Guidance July 5 Financial Transparency and Efficiency of the Prescription (..)

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Agency IQ

SEPTEMBER 15, 2023

According to the FDA’s agenda, linked above, and the meeting minutes , Leslie Hendeles, Randy Hatton, and Jonathan Shuster of the University of Florida gave presentations supporting the assertions they had made in their petition. CHPA supplemented the FDA’s presentation on retail volume with survey results on consumer preferences.

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Alta Sciences

JULY 25, 2024

Watch the poster presentation. TOP MANUFACTURING AND ANALYTICAL SCIENTIFIC RESOURCES Podcast: Successful Manufacturing of Clinical Trial Supply Join our formulation and pharmacy experts as they share insider secrets for overcoming clinical trial challenges and resolving issues that could impact your drug development program's timeline.

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Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

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Alta Sciences

OCTOBER 30, 2023

TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. The Altascientist : Issue No. Read or listen now. Watch the video.

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Agency IQ

MARCH 1, 2024

Government shutdown: At present, the FDA has appropriated funding lasting until midnight on Friday, March 1. Given that the rule is currently under White House review, we’re expecting this to soon be released. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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Agency IQ

DECEMBER 1, 2023

Government shutdown: At present, the FDA has appropriated funding through January 19. Both sections 503A and 503B provide that a compounded drug is not eligible for those exemptions if it is identified by FDA as presenting demonstrable difficulties for compounding.

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Agency IQ

FEBRUARY 2, 2024

Government shutdown: At present, the FDA has appropriated funding March 1. QMSR final rule : For years, the FDA has been talking about harmonizing its Quality System Regulation with ISO 13485:2016, which it would incorporate by reference. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

raw scores, standardized norm-referenced scores), some of which might present floor or ceiling effects; and ensuring that selected COAs have demonstrated reliability across demographic groups. In this gene therapy guidance, FDA states that: “the recommended [long-term follow-up].

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Drug Target Review

NOVEMBER 27, 2024

Finally, its application in urine samples presents additional challenges compared to serum. Clinical Pharmacology & Therapeutics. Outsourcing Biomarkers in Clinical Trials: Advantages and Disadvantages. Available from: [link] Bakker E, Hendrikse NM, Ehmann F, et al. 2022 Mar 5;112(1):69–80. 174-177.

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